Alta Sciences

JANUARY 31, 2024

Pharmacokinetics, Pharmacodynamics and Toxicokinetics Demystified pmjackson Wed, 01/31/2024 - 14:55 Understanding the effects of a drug, and how it interacts with the body, and vice versa, is critical to ensure it is safe for human use. This is where pharmacokinetic (PK), pharmacodynamic (PD) , and toxicokinetic (TK) analyses step in.

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Alta Sciences

FEBRUARY 19, 2025

Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development pmjackson Wed, 02/19/2025 - 21:30 The unique physicochemical properties of oligonucleotides require the use of specialized bioanalytical approaches, with key considerations including selectivity and specificity, sensitivity, stability, and matrix effects.

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Drug Development Clinical Pharmacology Immune Response Drugs 52

Chemical Biology and Drug Design

AUGUST 18, 2024

ABSTRACT To increase the success rate of drug discovery, one practical strategy is to begin molecular hybridisation. Benzimidazole and oxadiazole are privileged structures in medicinal chemistry and are widely used in drug discovery and development due to their vast biological properties.

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Chemical Biology and Drug Design

JANUARY 29, 2024

In silico ADME prediction of these compounds revealed the good drug-likeness nature and followed Lipinski's rule of five. Abstract In this article, we described synthesis of 1,3-thiazolidine - amide hybrid derivatives by two different methods from ( S )-2-amino-3-(4-(benzyloxy)phenyl)-1-(thiazolidin-3-yl)propan-1-one (4).

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Drug Target Review

DECEMBER 11, 2024

This shift in focus is especially critical in toxicology, where accurate target analysis plays a vital role in identifying toxic effects and ensuring patient safety, particularly as the field transitions from traditional drugs to the promising realm of biotherapeutics, especially for rare diseases.

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International Laboratories Drugs Pharmacokinetics 52

Elrig

MARCH 25, 2025

Prof Rory Johnson, Associate Professor, University College Dublin, and Dr Shalini Andersson, Vice President Nucleic Acid Therapeutics, AstraZeneca will lead this years event focussed on drugging the undruggable. Dr Andersson has authored over 70 peer-reviewed articles and is a named inventor on six patents.

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RNA Bioinformatics Science Pharmacokinetics 59

Chemical Biology and Drug Design

DECEMBER 19, 2024

The results of invivo anti-inflammatory tests showed that compound 5k was the most potent of the mollugin derivatives with an inhibition rate of 81.77%, which was significantly more potent than or the positive control drugs (ibuprofen and mesalazine).

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Chemical Biology and Drug Design

MARCH 7, 2024

The physicochemical, pharmacokinetic, drug-like, and drug-score features of all synthesized compounds were assessed using the online Swiss ADME and Protein Plus software. All of them met Lipinski's rule of five and had drug-likeness and drug score values of 0.55 AutoDock 4.2 kJ/mol, respectively.

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Pharmacokinetics Drugs Research 100

Chemical Biology and Drug Design

MARCH 5, 2024

The outcomes of the tested compounds 5d , 5e , and 5f have shown more potent activity when compared to the standard drug erlotinib. The potent compounds 5d , 5e , and 5f were subjected to in silico pharmacokinetic assessment by SWISS, ADME, and pkCSM.

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Pharmacokinetics Drugs Research 100

Drug Target Review

MARCH 17, 2025

Advancing drug candidates across key therapeutic areas Dr John Donello brings over 25 years of experience in pharmaceutical drug discovery, development and collaborations. An NMDA receptor modulator is a drug that targets the NMDA receptor in the brain, which is crucial for processes like synaptic plasticity, learning and memory.

Treatment 52

Treatment Licensing Licensing Science 52

New Drug Approvals

APRIL 18, 2025

2] [3] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [4] 1] [2] Adverse effects The US Food and Drug Administration prescription label for crinecerfont has a warning for acute adrenal insufficiency or adrenal crisis. [2] Food and Drug Administration (FDA) (Press release). January 2025.

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Chemical Biology and Drug Design

MARCH 6, 2024

Thus, polonilignan has been identified as a new pan-cytokine and NO inhibitor, it is recommended to optimise a method for the synthesis of this small molecular weight lignan and explore its pharmacokinetic characteristics, toxicity and therapeutic effect under various chronic inflammatory disease models.

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Pharmacokinetics Regulations Disease Production 100

Alta Sciences

APRIL 17, 2024

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues.

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Molecular Design

MARCH 26, 2024

Encountering words like “truth” and “beauty” (here's a good example ) in the titles of scientific articles always sets off warning bells for me and I’ll kick off blogging for 2024 with a look at FM2024 (Structure is beauty, but not always truth) that was recently published in Cell.

Drugs 60

Drugs Pharmacokinetics Cell Based Assays Treatment 60

Metabolite Tales Blog

APRIL 10, 2024

Where data was publicly available, the routes of human metabolism for each of the drugs in this subset is listed in Table 1. Metabolites found in humans are also observed in monkeys, and all metabolites were found to possess <10% of the activity of the parent drug. of the administered radiolabel in the human ADME study.

Small Molecule 59

Small Molecule FDA Approval FDA Pharmacokinetics 59

Agency IQ

AUGUST 11, 2023

While the notice itself does not spell out “BEST,” AgencyIQ would assume it means the Biologics Effectiveness and Safety (BEST) System , a branch of the FDA’s active surveillance initiative for drug products, Sentinel.

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Molecular Design

JULY 18, 2020

Satchel Paige (1906-1982) The COVID Moonshot and OSC19 are examples of what are sometimes called crowdsourced or open source approaches to drug discovery. Open source drug discovery originated with OSDD in India and it should be noted that the approach has also been pioneered for malaria by OSM.

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Biochemical Assays Fragment Screening Pharmacokinetics Drugs 52

Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. First, nearly all psychedelics are Schedule I drugs under the Controlled Substances Act (CSA).

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Molecular Design

MAY 11, 2019

I'll examine an article entitled ‘Mapping the Efficiency and Physicochemical Trajectories of Successful Optimizations’ (YL2018) in this post and I should note that the article title reminded me that abseiling has been described as the second fastest way down the mountain.

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Molecular Design

FEBRUARY 7, 2023

We commonly invoke the free drug hypothesis (FDH) in drug design which means that we assume that the free concentration at the site of action is the same as the free plasma concentration (the term ‘free drug theory’ is also commonly used although I prefer FDH).

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Pharmacokinetics Small Molecule Disease Clinical Trials 40

Vial

MARCH 15, 2024

This article explores the roles of CROs and highlights strategic partnerships between CROs and external vendors, designed to enhance research outcomes. Additionally, the article discusses difficulties inherent in managing clinical trials and emphasizes the indispensable contributions of sponsors in the trial.

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Agency IQ

DECEMBER 11, 2023

The recommendations in the guidance are intended to apply to a broad scope of products regulated by the agency – including drugs, biological products and medical devices, which fall under the purviews of the Centers for Drug and Biologics Evaluation and Research (CDER and CBER), and the Center for Devices and Radiological Health (CDRH).

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Metabolite Tales Blog

JANUARY 23, 2024

Metabolism of 2023 FDA Approved Small Molecules – PART 1 By Julia Shanu-Wilson 2023 was a fruitful year for drug approvals by the FDA, with a crop of 34 small molecules out of a total of 55 new drugs [1]. This constitutes an interesting subset of 9 drugs, constituting over 25% of the new small molecule drug approvals in 2023!

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Alta Sciences

SEPTEMBER 13, 2023

COMMONLY USED PAIN MODELS As pain models continue to expand, there are still many tried and tested ways to achieve the most accurate results possible, such as pain stimulation, pharmacodynamics (PD), and pharmacokinetics (PK) for early phase analgesic trials. At Altasciences , we have extensive experience testing various pain models.

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Clinical Trials Treatment Trials Drug Development 52

Agency IQ

MAY 17, 2024

How have pre-submission meetings for generic drug applicants changed under GDUFA III? Under GDUFA III, the scope and purpose of pre-submission meetings for generic drug developers has changed. One of the core goals of the GDUFA program has been to increase the efficiency of the generic drug review program.

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Science FDA Drugs Production 40

Agency IQ

SEPTEMBER 15, 2023

FDA’s nonprescription advisors find no efficacy for phenylephrine This week, FDA’s Nonprescription Drugs Advisory Committee (NDAC) voted unanimously that current scientific data do not support the efficacy of oral phenylephrine as a nasal decongestant, aligning with FDA analysis — and re-analysis — of data.

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The Pharma Data

NOVEMBER 4, 2020

Food and Drug Administration (FDA) Breakthrough Therapy and Fast Track Designations, is now in pivotal testing, and CTP-692 for schizophrenia is currently on track for topline data readout in the first quarter of 2021,” said Roger Tung, Ph.D., CTP-543 for moderate to severe alopecia areata, which received U.S.

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Pharmaceuticals Clinical Trials Trials Treatment 52

Agency IQ

AUGUST 9, 2024

estimated prevalence of the condition of interest, any relevant pharmacokinetic or pharmacogenomic data, demographic factors) and how they intend to meet those goals, as well as operational and process factors such as how they should be submitted and how the “action plan” may be updated over time. What does that mean: a “new drug”?

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Science FDA Production Trials 40

Agency IQ

FEBRUARY 23, 2024

Workshop addresses oncology dose optimization across full span of development In a series of broad-ranging, frank discussions, attendees at a joint FDA-American Association of Cancer Research (AACR) workshop worked through opportunities and challenges for dose optimization across the span of cancer drug development activities.

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Science FDA Trials Clinical Pharmacology 40

Agency IQ

JULY 26, 2024

Changes that have a moderate potential to have an adverse effect on the identity, strength, purity, or potency of a drug constitute moderate changes. A CP is a well-defined, detailed, written plan for assessing the effect of specific CMC changes in the identity, strength, quality, purity, and potency of a specific drug product.

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Alta Sciences

APRIL 24, 2025

And in this case study, we demonstrate how we used a proactive strategy to establish a clear differentiation between anticipated pharmacological responses and potential safety-related findings and to provide the client with high-quality toxicology and pharmacokinetic data crucial for their IND submission.

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Small Molecule Pharmacokinetics Treatment Compliance 52

Agency IQ

JULY 28, 2023

First, an audit of communications and meeting management under the Prescription Drug User Fee Act (PDUFA) Quick background: As AgencyIQ has previously discussed, the FDA collects user fees as part of an essential bargain between regulators and industry. This week, FDA posted several new special notice contract opportunities on SAM.

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The Anticancer Fund

APRIL 1, 2022

1 April 2022 Language EN Drug repurposing is a strategy for identifying new uses for approved drugs, outside the scope of the original indication. Below, we have listed recent findings about the repurposing of generic drugs in oncology. Being listed is no endorsement of the results and conclusions of the article.

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Clinical Trials Drugs Trials Pharmacokinetics 40

Agency IQ

FEBRUARY 2, 2024

The document has been updated over time to implement advances in understanding cancer and drug development. In 2005, the guidance was updated to include non-cytotoxic drugs were gaining in importance. measure of drug activity versus patient selection). For example, the first three editions focused on cytotoxic compounds.

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Agency IQ

OCTOBER 20, 2023

In terms of general drug development considerations during the early phase, sponsors should consider obtaining Phase 1 data that demonstrate that the candidate drug has adequate penetration to the outer skin layers, after consultation with the agency about drug penetration study technique.

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FDA Treatment Trials Therapies 40

Agency IQ

FEBRUARY 23, 2024

Overdue EMA reflection paper on drug dosing in obesity introduces more questions than answers Although the prevalence of overweight and obesity in Europe exceeds 50%, the EMA does not currently offer guidance to sponsors on investigating the effects of obesity during drug development.

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Drugs Clinical Trials Pharmacokinetics Drug Development 40

Alta Sciences

APRIL 11, 2025

Best Practices for Preclinical Dose Range Finding Studies pmjackson Fri, 04/11/2025 - 20:05 Dose range finding (DRF) studies are the foundation of preclinical drug development, providing crucial information on safety data to assist in the dose level selection before advancing into toxicology studies.

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